Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 191
- 试验地点
- 5
- 主要终点
- Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy
研究概览
简要总结
Long term corticosteroid therapy concerns 0.5 to 1% of the population and about 2.5% of elderly subjects. It is currently used as a cornerstone therapy in a wide variety of clinical contexts. The central problematic of prolonged corticosteroid therapy is the burden of adverse events associated with its long term use, including bone, metabolic and infectious complications.
The management of patients for whom the prescription of long term corticosteroid therapy is indicated should include an evaluation of the individual risk and implementation of the appropriate preventive measures. Such an approach should particularly include cortisonic osteoporosis prevention, infectious prevention including vaccination, prevention of adrenal insufficiency, promotion of physical activity, as well as dietary management.
In France, nurse-led prevention programs are highly developed for patients initiating immunosuppressive targeted therapies. Conversely, there are no dedicated nurse-led programs for patients starting prolonged corticosteroid therapy, for several historical and economical reasons.
The implementation of such programs is likely to be beneficial at different levels, including the reduction of the number of adverse events and improvement of health-related quality of life.
The main objective of the study is to determine the long-term benefit of a nurse-led prevention program among patients starting long-term corticosteroids therapy, compared to routine care.
详细描述
It is a PROBE (Prospective Randomized Open trial with a Blind Evaluation) study, in which the primary endpoint will be assessed at week-52 by an independent physician blinded to the participant's allocation group.
The target population is adult patients initiating a first sequence of long term corticosteroid therapy, to the exception of onco-hematological indications, severe chronic renal failure and organ transplant.
Patients in both groups will have baseline and week-52 standardized visits including clinical evaluation, routine biology, dual-energy X-ray absorptiometry and quality of life assessment (SF-36). Corticosteroid consumption will be collected throughout the study using a dedicated notebook. At the week-52 visit, the burden of adverse events related to the use of corticosteroids will be assessed through the glucocorticoid toxicity index (GTI), completed by the blinded physician.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patients aged 18 or older
- Initiation of corticosteroids within 30 days prior to inclusion
- Estimated cumulative dosage of corticosteroids ≥ 2000 mg
- Affiliated member of the social security system
排除标准
- Patients unable to give consent or unable to understand the protocol
- A patient who is not 'or is no longer' able to communicate remotely by telephone could not 'or no longer' be included in the study.
- Patients under guardianship
- Previous exposure to long-term corticosteroids
- Prescription of corticosteroids for the management of malignant neoplasms
- Severe chronic renal failure with clearance of creatinine < 30 ml/min.
- History of organ transplantation
- Pregnant or breastfeeding women
研究组 & 干预措施
Nurse-led prevention program
Patients will receive a general summary sheet of preventive measures associated with long term corticosteroids therapy (no individual assessment) in addition to the usual care provided by their physician
干预措施: nurse-led prevention program (Other)
Standard of care
Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)
干预措施: Current care (Other)
结局指标
主要结局
Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy
时间窗: 12 months
Glucocorticoid Toxicity Index Raw Score
次要结局
- Cumulative glucocorticoid dosage actually received(12 months)
- Following of the quality of life(12 months)
- The occurrence of different categories of complications of long-term corticosteroid therapy(12 months)
- occurrence of at least one clinically significant complication of steroid therapy(12 months)
- Application of preventive drug measures(12 months)
研究者
研究点 (5)
标识符
- NCT 编号
- NCT04909606
- 其他研究编号
- 29BRC20.0119
日期
- 首次提交
- (5年前)
- 首次发布
- (5年前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (7个月前)
- 最近更新
- (6个月前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
All collected data that underlie results in a publication